| CTRI Number |
CTRI/2026/02/104563 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Randomized and Crossover Trial Nasopancreatic Lidocaine vs. Saline for Post-ERCP Pain in Chronic Pancreatitis participants |
|
Scientific Title of Study
|
Randomized Double-Blind Crossover Clinical Study of Nasopancreatic Lidocaine versus Saline Infusion for Immediate Post-ERCP Pain Relief in Patients with Chronic Pancreatitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NP-LIDO/CT/2025/01 Version: 2.0 Date: 31-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Rahate |
| Designation |
Director and Consultant Surgeon |
| Affiliation |
Seven Star Hospital |
| Address |
Seven Star Hospital at great Nag Road,near Jagnade Square, KDK college Road, Nandanvan Nagpur 440009,Maharashtra
Nagpur
MAHARASHTRA
440009
India |
| Phone |
09822464068 |
| Fax |
|
| Email |
prashantrahate84@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Rahate |
| Designation |
Principal Investigator |
| Affiliation |
Seven Star Hospital |
| Address |
Department of Gastroenterology
Seven Star Hospital 324 1 Great Nag Rd Jagnade Square Nandanwan Nagpur Maharashtra 440009
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9822464068 |
| Fax |
|
| Email |
prashantrahate84@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Founder and Managing Director |
| Affiliation |
IR Innovate Research Pvt.LTd |
| Address |
IR Innovate Research Pvt Ltd
Building C-120 3rd Floor
Sector 2 Noida 201301
Gautam Buddha Nagar
UTTAR PRADESH
110034
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| Seven Star Hospital at Jagnade Square, KDK college Road, Nandanvan Nagpur
MAHARASHTRA
440009
India |
|
|
Primary Sponsor
|
| Name |
DrPrashant Rahate |
| Address |
Seven Star Hospital 324 1 Great Nag Rd Jagnade Square Nandanwan Nagpur Maharashtra 440009 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant Rahate |
Seven Star Hospital |
Department of Gastroenterology
Seven Star Hospital 324 1 Great Nag Rd Jagnade Square Nandanwan Nagpur Maharashtra 440009
Nagpur
MAHARASHTRA |
9822464068
-
prashantrahate84@yahoo.com |
| Dr Saad A Rahman |
Tender Palm Super Speciality Hospital |
Department of Gastroenterology Tender Palm Super Speciality Hospital Amar shaheed path near Ekana international cricket stadium road sector 7 gomti nagar lucknow uttar pradesh 226002
Lucknow
UTTAR PRADESH |
8826225592
saadrahman0786@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee Rahate Surgical Hospital |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K861||Other chronic pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% normal saline |
The comparator is 0.9% normal saline, used as a placebo control. |
| Intervention |
2% preservative-free lidocainesolution |
The investigational product is 2% preservative-free lidocainesolution, administered via a nasopancreatic tube for immediate post-ERCP pain relief. The study duration for each subject is 01 day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Eligibility of the subjects will be evaluated on Day 1 and individual subject must meet all the following criteria to be considered eligible for participating in the study
1 Both male and female adults aged more than 18 years
2 Established diagnosis of painful chronic pancreatitis confirmed by prior clinical evaluation and imaging with or without evidence of pancreatic insufficiency
3 Undergoing ERCP with pancreatic duct cannulation for diagnostic or therapeutic purposes as per standard of care
4 Report a post-ERCP pain score greater than or equal to 2 on a 0 10 Numeric Rating Scale (NRS) upon recovery from anesthesia |
|
| ExclusionCriteria |
| Details |
Individuals who meet any of the following criteria will be considered ineligible forparticipating in the study
1 Known allergy or hypersensitivity to lidocaine or other amide-type local anesthetics
2 History of severe adverse reactions to lidocaine including anaphylaxis
3 History of methemoglobinemia or significant hemoglobinopathy
4 Presence of severe cardiac conduction abnormalities such as
Wolff-Parkinson-White syndrome
Stokes-Adams syndrome
Severe heart block sinoatrial atrioventricular or intraventricular
5 Significant hepatic impairment which may reduce lidocaine metabolism
6 Severe renal insufficiency particularly in the context of multiple lidocaine doses due toreduced metabolite clearance
7 Heart failure or unstable cardiac disease unless clinically indicated and closelymonitored
8 Pregnant or breastfeeding women
9 Body weight less than 40 kg
10 Inability to communicate or understand the study protocol requirements
11 Concurrent use of medications that may interfere with lidocaine metabolism such ascimetidine beta-blockers
12 Recent myocardial infarction within the past 6 months
13 Use of systemic corticosteroids or chronic opioid therapy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint will evaluate the changein pain score (Numeric Rating Scale NRS) frombaseline to 15 minutes after each infusion(lidocaine or saline) |
baseline to 15 minutes after each infusion(lidocaine or saline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of Pain Responders
To assess the proportion of patients who achieve clinically significantpain relief following nasopancreatic lidocaine infusion defined as areduction of greater than or equal to 2 points on the Numeric RatingScale or a final NRS score less than 2
Safety and Tolerability
To evaluate the safety and tolerability of nasopancreatic lidocaineinfusion by documenting the incidence severity and type of adverseevents during and after the procedure
Lidocaine Plasma Concentration and Clinical Correlation
To measure plasma lidocaine levels following nasopancreatic infusionand explore their correlation |
Proportion of PainResponders
Timepoint: 15 minutes post-infusion
Safety and Tolerability
Timepoint: During ERCP andup to 24 hours post-procedure or until discharge
Lidocaine PlasmaConcentration and ClinicalCorrelation
Timepoints: 15 minutes and30 minutes post-infusion |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, double blind, two treatment, two period crossover clinical study designed toevaluate the effectiveness of nasopancreatic lidocaine infusion in reducing immediate postprocedure pain in patients with chronic pancreatitis undergoing ERCP. Each subject will receive bothtreatments lidocaine and normal saline in two separate ERCP sessions. Pain will be assessed usingthe Numeric Rating Scale at baseline and fifteen minutes after the infusion. The study also aims toevaluate the safety and tolerability of lidocaine infusion by monitoring adverse events, and tomeasure plasma lidocaine concentrations to explore their correlation with pain relief. 8/13/25, 3:29 PM CTRI https://ctri. |